Would You Randomize Before Consent? Lessons from EDI and Zelen’s Design Dilemma
What happens when the ideal design for scientific clarity clashes with our instincts for patient autonomy? The Early Detection Initiative (EDI) for pancreatic cancer started with a bold design—then changed course. Here’s why it matters. Act I: The Trial That Got Ethics Committees Buzzing Imagine you’re reviewing
When the p-value Was Enough: Rethinking Trial Design Through ISIS-2
A simple trial. A massive effect. A p-value so small it didn’t need confidence intervals. In 1988, ISIS-2 didn’t just change cardiology—it proved that 162mg of aspirin could prevent 1 in 40 deaths. And it reminded statisticians what trial design is supposed to do: answer questions that matter. Act

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Jamie Larson
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